Heart FailurePhase 2CONVERGE-HFNCT06601465
COgnitioN With VERiciGuat Evaluation in Heart Failure
A Phase 2 study testing Vericiguat in people with Heart Failure and Cognitive Impairment, run by University of Alberta at 4 sites in Canada.
Trial summary
CONVERGE-HF is a 4-center pilot phase IIb randomized control trial in ambulatory patients with chronic heart failure (≥ 6 months) and mild-to-moderate cognitive impairment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Cognitive Impairment
- What is being tested?
- Vericiguat
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 4 sitesCanada
- Study dates
- 3 Jun 2025to 16 Jul 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients
- Established chronic heart failure (≥ 6 months)
- Mild-to-moderate cognitive impairment (as per the diagnosis of cognitive impairment or a Montreal Cognitive Assessment (MoCA) score 10-25).
Who cannot join
- Patients who have contraindications for sGC stimulator and vericiguat therapy (i.e. use of long-acting nitrates, other soluble guanylate cyclase stimulators (e.g., riociguat), or phosphodiesterase type 5 (PDE-5), pregnancy or breast-feeding)
- Unable to undergo CMR imaging or brain MRI.
- CMR exclusions: incompatible implantable cardiac device (ICD or CRT), uncontrolled atrial fibrillation or recurrent ventricular arrhythmias).
- General medical conditions: uncontrolled thyroid disorders, hepatic failure, or myocardial revascularization procedures [coronary angioplasty and/or surgical revascularization in the previous 3 months], cancer/malignancy, or with severe dementia).
- Patients with allergies to the study products.
- Patients currently hospitalized.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada4 sites, 4 recruiting
- Recruiting
University of Calgary
Calgary, Alberta
- Recruiting
University of Alberta
Edmonton, Alberta
- Not yet recruiting
McGill University Health Center
Montreal, Quebec
- Recruiting
University of Ottawa
Ottawa, Ontario
About this study
Official title: CONVERGE-HF: COgnitioN With VERiciGuat Evaluation in Heart Failure
CONVERGE-HF is a 4-center pilot phase IIb randomized control trial in ambulatory patients with chronic heart failure (≥ 6 months) and mild-to-moderate cognitive impairment.
Read the detailed description
CONVERGE-HF is a randomized, open label, phase IIb trial evaluating the effect of sGC stimulator, Vericiguat versus standard of care on imaging markers and blood markers of cerebral and coronary small vessel diseases, function status, cognitive status, quality of life and clinical events in patients with heart failure and mild-to-moderate cognitive impairment. Patients will be randomized and allocated to either vericiguat or standard of care, for 26 weeks including the greater than 4 weeks timeframe for the uptitrations to the target dose.
- Conditions
- Heart Failure, Cognitive Impairment
- Being tested
- Vericiguat
- Keywords
- Heart Failure, Cognitive Impairment, Vericiguat
- Medical subject headings
- Heart Failure, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VericiguatDrug
Also called Verquvo
Tablet - 2.5 mg, 5 mg, 10 mg
| Study group | Role | What they receive |
|---|---|---|
| Vericiguat | Experimental | A starting dose of 2.5 mg of vericiguat taken orally once daily with food, on a background of HF standard of care. Uptitrated gradually every 2 weeks to 5 mg daily and then to the target dose of 10 mg daily. Receives: Drug: Vericiguat |
| Standard of Care | No intervention | Conventional management of heart failure and mild-to-moderate cognitive impairment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the lateral ventricular volumes.
To determine whether in patients with heart failure and mild-to-moderate cognitive impairment, the 26 weeks of treatment with sGC stimulator, vericiguat versus standard of care lead to greater reduction (or smaller increase) in lateral ventricular volume in brain MRI as a proxy for the preservation of brain microvasculature and preventing brain tissue loss.
Measured: 26 weeks
Secondary outcomes (13)
Blood Biomarkers (a)
To determine the difference in the change in cardiac ischemia and strain markers measured by cardiac troponin, IGFBP-7, and NT-proBNP between patients with heart failure and mild-to-moderate cognitive impairment who were treated for 26 weeks with sGC stimulator, vericiguat versus standard of care.
Measured: 26 weeks
Blood Biomarkers (b)
To determine the difference in the change of brain-related marker of cis p-tau between patients with chronic CV disease and mild-to-moderate cognitive impairment who were treated for 26 weeks with sGC stimulator, vericiguat versus standard of care.
Measured: 26 weeks
Imaging Biomarkers (Cardiac)
To determine the difference between patients with heart failure and mild-to-moderate cognitive impairment who were treated for 26 weeks with sGC stimulator, vericiguat, versus standard of care in terms of the change in CMR perfusion test results for perfusion deficits indicative of coronary microvascular impairment.
Measured: 26 weeks
Imaging Biomarkers (Brain)
To determine the difference between patients with heart failure and mild-to-moderate cognitive impairment who were treated for 26 weeks with sGC stimulator, vericiguat versus standard of care in terms of the change in brain MRI peak skeletonized mean diffusivity of the white matter and change in white matter hypersensitivity volume indicative of cerebral small vessel disease.
Measured: 26 weeks
Clinical and patient-reported outcomes (MoCA)
To compare the change of MoCA scores in 26 weeks between groups who were treated with vericiguat versus standard of care.
Measured: 26 weeks
Clinical and patient-reported outcomes (KCCQ-12)
To compare the change of health-related quality of life (assessed via KCCQ-12) in 26 weeks between groups who were treated with vericiguat versus standard of care. The KCCQ-12 has a standardized format and has been validated for paper, electronic or telephone delivery.
Measured: 26 weeks
Clinical and patient-reported outcomes (6MWT)
To compare the change of functional status assessed via 6-minute walk test (6MWT) in 26 weeks between groups who were treated with vericiguat versus standard of care. The 6MWT will be performed as outlined by the American Thoracic Society by an assessor blinded to treatment allocation.61 6MWT will be assessed both in-person and using the validated virtual approach utilizing Walk.Talk.Track app.
Measured: 26 weeks
Clinical and patient-reported outcomes (RBANS)
To compare the change of Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) scores between groups. The RBANS is a widely-used battery for identifying and characterizing abnormal cognitive decline in elderly adults. Its level of difficulty is appropriate for the range from normal cognition to moderately severe dementia.
Measured: 26 weeks
Clinical events - Death
(all cause)
Measured: 26 weeks
Clinical events - Hospitalizations
(all cause)
Measured: 26 weeks
Clinical events - Emergency Department Visits
(all cause)
Measured: 26 weeks
Clinical events - Stroke
Measured: 26 weeks
Clinical events - Other
Measured: 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start3 Jun 2025
- Primary completion16 Jul 2028 (estimated)
- Study completion16 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Ottawa Heart Institute Research Corporation, Heart and Stroke Foundation of Canada
- Responsible party
- Sponsor
- Investigators
- Justin Ezekowitz, MBBCh, MSc, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06601465
- Sponsor's protocol ID
- CONVERGE-HF-2023-6
- Acronym
- CONVERGE-HF
- Status last verified
- Aug 2026
- First submitted
- 6 Sep 2024
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There are no plans to share IPD at this time.
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CONVERGE-HF: COgnitioN With VERiciGuat Evaluation in Heart Failure
- ClinicalTrials.gov ID
- NCT06601465
- Acronym / sponsor ID
- CONVERGE-HF / CONVERGE-HF-2023-6
- Conditions
- Heart Failure, Cognitive Impairment
- Keywords
- Heart Failure, Cognitive Impairment, Vericiguat
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- Ottawa Heart Institute Research Corporation, Heart and Stroke Foundation of Canada
- Study start
- 3 Jun 2025 (actual)
- Primary completion
- 16 Jul 2028 (estimated)
- Study completion
- 16 Jul 2028 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
CONVERGE-HF is a 4-center pilot phase IIb randomized control trial in ambulatory patients with chronic heart failure (≥ 6 months) and mild-to-moderate cognitive impairment.
Detailed description
CONVERGE-HF is a randomized, open label, phase IIb trial evaluating the effect of sGC stimulator, Vericiguat versus standard of care on imaging markers and blood markers of cerebral and coronary small vessel diseases, function status, cognitive status, quality of life and clinical events in patients with heart failure and mild-to-moderate cognitive impairment. Patients will be randomized and allocated to either vericiguat or standard of care, for 26 weeks including the greater than 4 weeks timeframe for the uptitrations to the target dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vericiguat | Experimental | Drug: VericiguatA starting dose of 2.5 mg of vericiguat taken orally once daily with food, on a background of HF standard of care. Uptitrated gradually every 2 weeks to 5 mg daily and then to the target dose of 10 mg daily. |
| Standard of Care | No intervention | –Conventional management of heart failure and mild-to-moderate cognitive impairment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients
- Established chronic heart failure (≥ 6 months)
- Mild-to-moderate cognitive impairment (as per the diagnosis of cognitive impairment or a Montreal Cognitive Assessment (MoCA) score 10-25).
Key exclusion criteria (6 listed)
- Patients who have contraindications for sGC stimulator and vericiguat therapy (i.e. use of long-acting nitrates, other soluble guanylate cyclase stimulators (e.g., riociguat), or phosphodiesterase type 5 (PDE-5), pregnancy or breast-feeding)
- Unable to undergo CMR imaging or brain MRI.
- CMR exclusions: incompatible implantable cardiac device (ICD or CRT), uncontrolled atrial fibrillation or recurrent ventricular arrhythmias).
- General medical conditions: uncontrolled thyroid disorders, hepatic failure, or myocardial revascularization procedures [coronary angioplasty and/or surgical revascularization in the previous 3 months], cancer/malignancy, or with severe dementia).
- Patients with allergies to the study products.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VericiguatAlso: VerquvoTablet - 2.5 mg, 5 mg, 10 mg | Drug | Vericiguat |
Primary outcome
Change in the lateral ventricular volumes.
Time frame: 26 weeks
To determine whether in patients with heart failure and mild-to-moderate cognitive impairment, the 26 weeks of treatment with sGC stimulator, vericiguat versus standard of care lead to greater reduction (or smaller increase) in lateral ventricular volume in brain MRI as a proxy for the preservation of brain microvasculature and preventing brain tissue loss.
13 secondary outcomes
Blood Biomarkers (a)
Time frame: 26 weeks
Blood Biomarkers (b)
Time frame: 26 weeks
Imaging Biomarkers (Cardiac)
Time frame: 26 weeks
Imaging Biomarkers (Brain)
Time frame: 26 weeks
Clinical and patient-reported outcomes (MoCA)
Time frame: 26 weeks
Clinical and patient-reported outcomes (KCCQ-12)
Time frame: 26 weeks
Clinical and patient-reported outcomes (6MWT)
Time frame: 26 weeks
Clinical and patient-reported outcomes (RBANS)
Time frame: 26 weeks
Clinical events - Death
Time frame: 26 weeks
Clinical events - Hospitalizations
Time frame: 26 weeks
Clinical events - Emergency Department Visits
Time frame: 26 weeks
Clinical events - Stroke
Time frame: 26 weeks
Clinical events - Other
Time frame: 26 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
- Individual participant dataSharing planned: No. There are no plans to share IPD at this time.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Justin Ezekowitz, MBBCh, MSc principal investigator
University of Alberta
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vericiguat in people with Heart Failure and Cognitive Impairment, run by University of Alberta at 4 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Justin Ezekowitz, MBBCh, MSc (780-492-0712, jae2@ualberta.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the lateral ventricular volumes. (time frame: 26 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2026; AzTrials last refreshed its copy on 3 Nov 2026.